Guideline No. 20a December 2006 Reviewed 2010

EXTERNAL CEPHALIC VERSION AND REDUCING THE INCIDENCE OF BREECH PRESENTATION

This is the first edition of this guideline. Methods of delivery for women with breech presentation is covered in RCOG Green-top Guideline No. 20b, The Management of Breech Presentation, published in December 2006.

1. Purpose and scope

External cephalic version (ECV) is the manipulation of the fetus, through the maternal abdomen, to a cephalic presentation. This guideline summarises the evidence regarding the routine use of ECV for breech presentation. The rationale behind ECV is to reduce the incidence of breech presentation at term and therefore the associated risks, particularly of avoidable caesarean section. The evidence concerning mode and technique of delivery of the persistent breech presentation is summarised in Green-top Guideline No. 20b, The Management of Breech Presentation.

2. Background

Breech presentation complicates 3–4% of all term deliveries and a higher proportion of preterm deliveries. It is more common where there has been a previous breech presentation. The incidence of caesarean section for breech presentation has increased markedly in the last 20 years and further1 with the publication of the term breech trial.2 This trial concluded that, at least for mortality and markers of intermediate term morbidity, elective caesarean section was safer for the fetus and of similar safety to the mother when compared with intention to deliver vaginally.3 This means that measures to reduce the incidence of breech presentation have become more important and that the effect of any such measure on the incidence of caesarean section will be more marked.

3. Identification and assessment of evidence

Evidence-based medicine reviews, including the Cochrane Register of Controlled Trials, were searched, together with the TRIP database for relevant randomised controlled trials, systematic reviews and meta- analyses. A search of Medline and PubMed (electronic databases) from 1966 to 2005 was also carried out. Search words included ‘breech’, ‘external cephalic version’, ‘fetal’, ‘tocolysis’ and ‘tocolytic agents’ and the search was limited to humans and English language.

4. External cephalic version 4.1 What is the impact of ECV on the incidence of breech presentation at delivery?

Women should be counselled that ECV reduces the chance of breech presentation at delivery. A

1 of 8 RCOG Guideline No. 20a ECV at term reduces the incidence of noncephalic presentation at delivery (RR 0.38, 95% CI 4 0.18–0.80, risk difference 52%, NNT 2). Spontaneous version rates for nulliparous women are Evidence approximately 8% after 36 weeks5 but less than 5% after unsuccessful ECV;6 success rates of ECV are level Ia 30–80%. Spontaneous reversion to breech presentation after successful ECV occurs in less than 5%.7,8

4.2 What is the effect of ECV on the caesarean section rate?

Women with a breech baby should be informed that attempting ECV lowers their chances of having a A caesarean section.

Labour with a cephalic presentation following ECV is associated with a higher rate of obstetric B intervention than when ECV has not been required.

ECV reduces the caesarean section rate by lowering the incidence of breech presentation (RR 0.55, 95% CI 0.33–0.91, risk difference 17%, NNT 6).4 Provision of an ECV service also reduces the 9 caesarean section rates for breech presentation. This reduction was not necessarily seen when and Evidence where unidentified breeches were more likely to be delivered vaginally.10 In current practice, level Ia breech babies are increasingly delivered by caesarean section, so the effect is likely to be more marked than the randomised trials.11,12

This reduction is in spite of a two-fold increase in intrapartum caesarean sections for successfully 13,14 turned babies, when compared with babies that were not breech at term. This is independent Evidence of an increased induction rate: both fetal and maternal indications for intervention are implicated.15 level III A small increase in instrumental delivery is also seen.

4.3 What is the success rate of ECV and what influences it?

Women should be counselled that, with a trained operator, about 50% of ECV attempts will be B successful but this rate can be individualised for them.

Results vary from 30% up to 80% in different series.7,16,17,18 Race, parity, uterine tone, liquor volume, engagement of the breech and whether the head is palpable, and the use of tocolysis, all affect the success rate.18,19 Published individual success rates may vary because of case selection as well as these factors. The highest success rates are seen with multiparous, non-white women with a relaxed 18 Evidence uterus, where the breech is not engaged and the head is easily palpable. Success rates are also level III higher with increasing liquor volume16,20 but, in practice, very high liquor volume may be associated with spontaneous reversion. Maternal weight, placental position, gestation, fetal size and position of the legs make less difference and are probably not independent of other factors.18 An overall success rate of 40% for nulliparous, and 60% for multiparous women can usually be achieved.

4.4 Does the use of tocolysis improve the success rate of ECV?

The use of tocolysis with beta-sympathomimetics may be offered to women undergoing ECV as it has A been shown to increase the success rate.

The use of tocolysis should be considered where an initial attempt at ECV without tocolysis has failed. P The success rate of ECV is increased by the use of tocolysis. This has been proven with ritodrine, salbutamol and terbutaline but not with glyceryl trinitrate (GTN) as a patch or sublingually,21 or Evidence with nifedipine. Intravenous and subcutaneous routes can be used. Data on those women who level Ia benefit most are contradictory. Tocolysis is also beneficial where an initial attempt without it has failed22 and can be attempted immediately. However, this policy has not been compared to tocolysis

RCOG Guideline No. 20a 2 of 8 for all. A simple protocol is to offer a slow intravenous or subcutaneous bolus of salbutamol or Evidence terbutaline either routinely or if an initial ECV attempt has failed. Women should be advised of the level Ia adverse effects of tocolysis with beta-2 agonists.

4.5 What other methods can be used to increase the success rate of ECV?

Where ECV fails the possibility of a further attempt should be discussed. P A later, second attempt, particularly with a second operator or where the back has been in the midline, may lead to a small increase in overall success rates but tocolysis markedly increases the success rate at a second attempt if it has not been used first.22 Other methods employed to increase success rates include the application of noise to the abdomen (fetal acoustic stimulation) where the back is in the midline,23 and regional analgesia, including after a failed initial attempt. For the latter, an increase in success rate is evident with epidural but not spinal analgesia.24 As maternal pain might indicate a complication, concerns regarding safety remain.

4.6 When should ECV be offered?

ECV should be offered from 36 weeks in nulliparous women and from 37 weeks in multiparous women. B ECV before 36 weeks of gestation is not associated with a significant reduction in noncephalic births or caesarean section.25 However, one controlled trial26 randomised women, where low spontaneous version rates were anticipated, to ECV at 34–36 or at 37–38 weeks of gestation. This demonstrated a non-significant reduction in noncephalic births and caesarean section in the early ECV group, although fewer women in the delayed ECV group underwent an ECV and a larger trial Evidence investigating this is continuing. Importantly, the trial did not show an increased preterm labour rate level IIb and confirmed the safety of early ECV and the low spontaneous reversion rate in this group. With a spontaneous version rate of 8% in nulliparous breeches after 36 weeks of gestation5 and the very low complication rate, ECV from 36 weeks of gestation in nulliparous women therefore seems a reasonable compromise.

There is no upper time limit on the appropriate gestation for ECV. Successes has been reported at 42 weeks of gestation7 and can be performed in early labour27 provided that the membranes are intact.

4.7 Is ECV safe?

Women should be counselled that ECV has a very low complication rate. B Women should be alerted to potential complications of ECV. P ECV is rarely associated with complications. Nevertheless, a few case reports exist of complications such as placental abruption, uterine rupture and fetomaternal haemorrhage. Randomised controlled trials4 have reported no evidence of an increase in neonatal morbidity and mortality (RR Evidence 0.44, 95% CI 0.07–2.92) but are underpowered for these rare outcomes. Systematic reviews report level III a very low complication rate6,28 but are subject to the limitations of reporting bias. These, and large consecutive series,7,29 however, suggest a 0.5% immediate emergency caesarean section rate and no excess perinatal morbidity and perinatal mortality.

ECV does not appear to promote labour7 but is associated with alterations in fetal parameters. These include a fetal bradycardia and a nonreactive cardiotocograph30 that are almost invariably transient, alterations in umbilical artery and middle cerebral artery waveforms31 and an increase in amniotic fluid volume.32 The significance of these is unknown.

3 of 8 RCOG Guideline No. 20a ECV should be performed where facilities for monitoring and immediate delivery are available. P The standard preoperative preparations for caesarean section are not necessary for women undergoing ECV. P ECV should be performed where ultrasound to enable fetal heart rate visualisation, cardiotocography and theatre facilities are available. Cardiotocography should be performed after the procedure. Kleihauer testing is unnecessary33 but anti-D immunoglobulin is normally offered to rhesus-negative women. Given the low complication rate, particularly when compared with labour, starvation, anaesthetic premedication and intravenous access are all unnecessary.

4.8 Is ECV painful?

Women should be advised that ECV can be painful and the procedure will be stopped if they wish. P ECV can be painful, with few women experiencing no discomfort and around 5% reporting high pain scores.22,33 The procedure may need to be stopped because of this. Reported experience of pain is greater where the procedure fails. Data on analgesia for ECV are lacking.

4.9 What are contraindications to ECV?

There are few absolute contraindications to ECV. C Absolute contraindications for ECV that are likely to be associated with increased mortality or morbidity:

● where caesarean delivery is required ● antepartum haemorrhage within the last 7 days ● abnormal cardiotocography ● major uterine anomaly ● ruptured membranes ● multiple pregnancy (except delivery of second twin).

Relative contraindications where ECV might be more complicated:

● small-for-gestational-age fetus with abnormal Doppler parameters ● proteinuric pre-eclampsia ● oligohydramnios ● major fetal anomalies ● scarred uterus ● unstable lie.

In one UK report without any adverse events, ECV was considered contraindicated in only 4% of women with a breech presentation at term.22 With an unstable lie, ECV is only logical in the context of a stabilising induction. There are few available data on this procedure, which should only be Evidence performed for a valid indication and may be associated with a significant intrapartum complication level III rate. The available data on ECV after one caesarean section are reassuring35,36 but are insufficient to confidently conclude that the risk is not increased.

5. Increasing the uptake of ECV

Local policies should be implemented to actively increase the number of women offered and undergoing ECV. B Obstetricians and midwives should be able to discuss the benefits and risks of ECV accurately. P

RCOG Guideline No. 20a 4 of 8 ECV may not be performed because breech is not diagnosed in about 25%37 because the procedure is not offered or available, because it was refused or because it was not recommended.38 Detection 39 Evidence rates can be increased through reminders to women and staff; ECV uptake rates can be increased level III by education of staff40 and are likely to be improved by accurate dissemination of the benefits and risks.

6. Alternatives to ECV

There is insufficient evidence to support the use of postural management as a method of promoting A spontaneous version over ECV.

Moxibustion should not be recommended as a method of promoting spontaneous version over ECV. A There is no evidence to support the use of postural management in the management of the breech presentation.41 Moxibustion, burnt at the tip of the fifth toe (acupuncture point BL67) has been 42 Evidence used to promote spontaneous version of the breech, with some success, and appears to be safe. level Ia However, pooled43 and recent data44 conclude that there is insufficient evidence to support its use, highlighting the need for good quality studies.

7. Developing an ECV service

An ECV service, provided by appropriately trained clinicians, should be available to all women with a C breech presentation at term.

All women undergoing ECV should be offered detailed information (preferably written) concerning the P risks and benefits of the procedure. Consent may also be appropriate.

ECV is best performed at a weekly session with access to ultrasound, cardiotocography and theatre facilities. ECV is not difficult and skills should be developed, if necessary, by visiting other hospitals. ECV can be performed by suitably trained midwives; experience with ultrasound is essential. Vigilance for breech presentation after 34 weeks is important. A proper understanding of the risks is essential for the obstetrician and midwife to allow accurate counselling. Local audit should be used to aid this.

8. Auditable standards

1. Antenatal detection of breech presentation. 2. Proportion of women with a breech presentation offered ECV. 3. Success rates of ECV. 4. Complications of/after ECV. 5. Maternal perceptions of ECV.

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5 of 8 RCOG Guideline No. 20a 8. Wallace RL, VanDorsten JP, Eglinton GS, Meuller E, McCart D, 27. Ferguson JE 2nd, Dyson DC. Intrapartum external cephalic Schifrin BS. External cephalic version with tocolysis. version. Am J Obstet Gynecol 1985;152:297–8. Observations and continuing experience at the Los Angeles 28. Nassar N, Roberts CL, Barratt A, Bell JC, Olive EC, Peat B. County/University of Southern California Medical Center. J Systematic review of adverse outcomes of external cephalic Reprod Med 1984;29:745–8. version and persisting breech presentation at term. Paediatr 9. Coltart T, Edmonds DK, al-Mufti R. External cephalic version at Perinat Epidemiol 2006;20:163–71. term: a survey of consultant obstetric practice in the United 29. Ben-Arie A, Kogan S, Schachter M, Hagay ZJ, Insler V. The impact Kingdom and Republic of Ireland. Br J Obstet Gynaecol of external cephalic version on the rate of vaginal and 1997;104:544–7. caesarean breech deliveries: a 3-year cumulative experience. 10. Nwosu EC, Walkinshaw S, Chia P, Manasse PR, Atlay RD. Eur J Obstet Gynecol Reprod Biol 1995;63:125–9. Undiagnosed breech. Br J Obstet Gynaecol 1993;100:531–5. 30. Hofmeyr GJ, Sonnendecker EW. Cardiotocographic changes 11. Vandenbussche FP, Oepkes D. The effect of the Term Breech after external cephalic version. Br J Obstet Gynaecol 1983; Trial on medical intervention behaviour and neonatal outcome 90:914–18. in The Netherlands: an analysis of 35,453 term breech infants. 31. Leung TY, Sahota DS, Fok WY, Chan LW, Lau TK. External BJOG 2005;112:1163. cephalic version induced fetal cerebral and umbilical blood 12. Royal College of Obstetricians and Gynaecologists Clinical flow changes are related to the amount of pressure exerted. Effectiveness Support Unit. National Sentinel Caesarean BJOG 2004;111:430–5. Section Audit Report. London: RCOG Press; 2001. 32. Brost BC, Scardo JA, Newman RB, Van Dorsten JP. Effect of fetal 13. Chan LY, Tang JL, Tsoi KF, Fok WY, Chan LW, Lau TK. Intrapartum presentation on the amniotic fluid index. Am J Obstet Gynecol cesarean delivery after successful external cephalic version: a 1999;181:1222–4. meta-analysis. Obstet Gynecol 2004;104:155–60. 33. Karantanis E, Alcock D, Phelan LK, Homer CS, Davis GK. 14. Vezina Y, Bujold E, Varin J, Marquette GP, Boucher M. Cesarean Introducing external cephalic version to clinical practice. Aust delivery after successful external cephalic version of breech N Z J Obstet Gynaecol 2001;41:395–7. presentation at term: a comparative study. Am J Obstet Gynecol 34. Fok WY, Chan LW, Leung TY, Lau TK. Maternal experience of 2004;190:763–8. pain during external cephalic version at term. Acta Obstet 15. Chan LY-S, Leung TK, Fok WY, Chan LW, Lau TK. High incidence Gynecol Scand 2005;84:748–51. of obstetric interventions after successful external cephalic 35. Flamm BL, Fried MW, Lonky NM, Giles WS. External cephalic version. BJOG 2002;109:627–31. version after previous caesarean section. Am J Obstet Gynecol 16. Boucher M, Bujold E, Marquette GP, Vezina Y. The relationship 1991;165:370–2. between amniotic fluid index and successful external cephalic 36. de Meeus JB, Ellia F, Magnin G. External cephalic version after version: a 14-year experience. Am J Obstet Gynecol 2003; previous cesarean section: a series of 38 cases. Eur J Obstet 189:751–4. Gynecol Reprod Biol 1998;81:65–8. 17. Nor Azlin MI, Haliza H, Mahdy ZA, Anson I, Fahya MN, Jamil MA. 37. Leung WC, Pun TC, Wong WM. Undiagnosed breech revisited. Br Tocolysis in term breech external cephalic version. Int J J Obstet Gynaecol 1999;106:638–41. Gynaecol Obstet 2005;88:5–8. 38. Caukwell S, Joels LA, Kyle PM, Mills MS. Women’s attitudes 18. Lau TK, Lo KWK, Wan D, Rogers M. Predictors of successful towards management of breech presentation at term. J Obstet external cephalic version at term: a prospective study. Br J Gynaecol 2002;22:486–8. Obstet Gynaecol 1997;104:798–802. 39. Roberts CL, Cameron CA, Nassar N, Raynes-Greenow CH. A 19. Hofmeyr GJ, Sadan O, Myer IG, Galal KC, Simko G. External simple patient-initiated intervention to increase antenatal cephalic version and spontaneous version rates: ethnic and detection of breech presentation at term. Paediatr Perinat other determinants. Br J Obstet Gynaecol 1986;93:13–16. Epidemiol 2004;18:371–6. 20. Haas DM, Magann EF. External cephalic version with an 40. Burr R, Johanson R, Wyatt J, Watt I, Jones P. A randomised trial of amniotic fluid index < or = 10: a systematic review. J Matern an intervention package designed to promote external Fetal Neonatal Med 2005;18:249–52. cephalic version at term. Eur J Obstet Gynecol Reprod Biol 21. Hofmeyr GJ. 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Cardini F, Lombardo P, Regalia AL, Regaldo G, Zanini A, Negri MG, facilitation of external cephalic version: a meta-analysis. Am J et al. A randomised controlled trial of moxibustion for breech Obstet Gynecol 2004;191:1219–24. presentation. BJOG 2005;112:743–7. 25. Hutton EK, Hofmeyr GJ. External cephalic version for breech presentation before term. Cochrane Database Syst Rev 2006; (1):CD000084. 26. Hutton EK, Kaufman K, Hodnett E, Amankwah K, Hewson SA, McKay D, Szalai JP, Hannah ME. External cephalic version beginning at 34 weeks’ gestation versus 37 weeks’ gestation: a randomized multicenter trial. Am J Obstet Gynecol 2003; 189:245–54.

RCOG Guideline No. 20a6of 8 APPENDIX

Clinical guidelines are: ‘systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions’. Each guideline is systematically developed using a standardised methodology. Exact details of this process can be found in Clinical Governance Advice No. 1: Guidance for the Development of RCOG Green-top Guidelines (available on the RCOG website at www.rcog.org.uk/clingov1). These recommendations are not intended to dictate an exclusive course of management or treatment. They must be evaluated with reference to individual patient needs, resources and limitations unique to the institution and variations in local populations. It is hoped that this process of local ownership will help to incorporate these guidelines into routine practice. Attention is drawn to areas of clinical uncertainty where further research may be indicated.

The evidence used in this guideline was graded using the scheme below and the recommendations formulated in a similar fashion with a standardised grading scheme.

Classification of evidence levels Grades of recommendations

Ia Evidence obtained from meta-analysis of A Requires at least one randomised randomised controlled trials. controlled trial as part of a body of literature of overall good quality and Ib Evidence obtained from at least one consistency addressing the specific randomised controlled trial. recommendation. (Evidence levels Ia, Ib) Requires the availability of well controlled IIa Evidence obtained from at least one B well-designed controlled study without clinical studies but no randomised clinical trials on the topic of recommendations. randomisation. (Evidence levels IIa, IIb, III) IIb Evidence obtained from at least one Requires evidence obtained from expert other type of well-designed quasi- C committee reports or opinions and/or experimental study. clinical experiences of respected authorities. Indicates an absence of directly III Evidence obtained from well-designed applicable clinical studies of good quality. non-experimental descriptive studies, (Evidence level IV) such as comparative studies, correlation studies and case studies. Good practice point

IV Evidence obtained from expert Recommended best practice based on the committee reports or opinions and/or P clinical experience of the guideline clinical experience of respected development group. authorities.

7 of 8 RCOG Guideline No. 20a This guideline was produced on behalf of the Guidelines and Audit Committee of the Royal College of Obstetricians and Gynaecologists by: Mr LWM Impey MRCOG, Oxford and Professor GJ Hofmeyr FRCOG, East London, South Africa and peer reviewed by: Mr Alok K Ash FRCOG, Consultant Obstetrician, Guy’s and St Thomas’ Hospital; British Association of Perinatal Medicine; British Maternal and Fetal Medicine Society; Dr AN Griffiths MRCOG; Cardiff; Professor M Hannah, Sunnybrook and Women’s Hospitals, Ontario; Dr B Kumar MRCOG, Wrexham; Obstetric Anaesthetists Association; RCOG Consumers’ Forum; Royal College of Midwives; Dr DM Siassakos, Specialist Registrar, Southmead Hospital, Bristol; Mr PJ Thompson FRCOG, Birmingham; Dr Evelyn Verheijen, Specialist Registrar, Royal Blackburn Hospital.

The Guidelines and Audit Committee lead peer reviewers were: Mr SA Walkinshaw FRCOG, Liverpool and Dr RG Hughes FRCOG, Edinburgh.

The final version is the responsibility of the Guidelines and Audit Committee of the RCOG.unless otherwise indicated.

DISCLAIMER

The Royal College of Obstetricians and Gynaecologists produces guidelines as an educational aid to good clinical practice. They present recognised methods and techniques of clinical practice, based on published evidence, for consideration by obstetricians and gynaecologists and other relevant health professionals. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor or other attendant in the light of clinical data presented by the patient and the diagnostic and treatment options available.

This means that RCOG Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to be prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or guidelines should be fully documented in the patient’s case notes at the time the relevant decision is taken.

This guideline was reviewed in 2010. A literature review indicated there was no new evidence available which would alter the recommendations and therefore the guideline review date has been extended until 2012, unless evidence requires earlier review.

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